Amgen, Pfizer, Alphabet and Uber face up to trade secrets in biosimilars, self driving cars and product launch plans

The AmeriKat ready for a Vertigo Hitchcock scene...

Once you notice something, you start to see it everywhere.  During her film studies class on Hitchcock almost 15 years ago, the AmeriKat was studying what would become her favorite film - Vertigo.  Like any artist, Hitchcock had a palette with which he painted his films - the most vivid arguably being Vertigo.  In the San Francisco-based mystery, he deployed contrasting green and red to draw attention to character identity.  Once you know this, you see it everywhere.  The same becomes true of IP law.  Once you notice an issue in IP, it starts to pop up everywhere you look - from the grocery store shelves, to news broadcasts and other cases (no matter how tangentially relevant).  During the past few weeks, it was the turn of trade secrets cases.  Every news alert, late night internet surfing session or conversation seemed to turn to the topic.  So what's been happening?

Can trade secrets stop Amgen's pegfilgrastim biosimilar nemesis?:  Last Friday, Amgen commenced a trade secret action alleging that Coherus BioSciences, a biosimilar manufacturer based in California, engaged in a concerted effort to poach Amgen's employees in order to obtain their trade secrets.  The information alleged to have been siphoned include lab notebooks, analytical methods, specifications and process optimization work. Coherus is progressing three late-stage clinical biosimilar products - pegfilgrastim (CHS-1701), etanercept and adalimumab. Amgen's pegfilgrastim product, sold under the brand name Neulasta, is used to reduce infection in cancer patients on chemotherapy and has been Amgen's top earner for years with 2016 bringing in $4.6 billion.  Coherus' CHS-1701 is slated for a 9 June 2017 FDA decision date.  Coherus' CEO, Denny Lanfear, rejected Amgen's allegations stating that:

"this lawsuit is best understood as an effort by Amgen to use baseless litigation in an effort to delay Coherus as a competitor in the pegfilgrastim market."

Lanfear continued:

"Coherus does not need Amgen’s proprietary information to compete or be successful. We are proud of Coherus’ novel clinical development strategy and novel clinical study designs that were never performed at Amgen and are not Amgen’s intellectual property."

Supplier e-mail tips off Alphabet in Uber trade secret battle:  At the end of February, Waymo, Alphabet's self-driving car company,  filed a complaint against Uber and Otto (a subsidiary that Uber bought last year) claiming that they have infringed its patents and misappropriated its trade secrets (the complaint is made under the Defend Trade Secrets Act and California Uniform Trade Secret Act).  Anthony Levandowski, who used to be employed by Waymo, was named Otto's founder.  Before he left, he allegedly downloaded 14,000 confidential files.   At the center of the dispute is LiDAR which stands for Light Detection and Ranging.  The technology is used to compile a 3D map by calculating the time (and thus distance) it takes light from pulsed laser beams to bounce off objects in the vicinity of a car.  This then enables the car to avoid crashing into nearby objects.   A note published on Waymo's website states that "hundreds of Waymo engineers have spent thousands of hours, and our company has invested millions of dollars to design a highly specialized and unique LiDAR system."  The note continues alleging the next sequence of events:

"Recently, we received an unexpected email. One of our suppliers specializing in LiDAR components sent us an attachment (apparently inadvertently) of machine drawings of what was purported to be Uber’s LiDAR circuit board — except its design bore a striking resemblance to Waymo’s unique LiDAR design. 

We found that six weeks before his resignation this former employee, Anthony Levandowski, downloaded over 14,000 highly confidential and proprietary design files for Waymo’s various hardware systems, including designs of Waymo’s LiDAR and circuit board. To gain access to Waymo’s design server, Mr. Levandowski searched for and installed specialized software onto his company-issued laptop. Once inside, he downloaded 9.7 GB of Waymo’s highly confidential files and trade secrets, including blueprints, design files and testing documentation. Then he connected an external drive to the laptop. Mr. Levandowski then wiped and reformatted the laptop in an attempt to erase forensic fingerprints."

Readers may recall that Google Ventures (parent company is Alphabet) was one of the investors in Uber.  According to this CNBC article, GV's original $258 million investment increased to $3.5 billion.  So a win in this case, may be some loss to the investment.  The complaint can be found here.

Senior marketing departure stokes suspicion, and then action, at Pfizer:  Last week, a Pennsylvania federal judge ordered an ex parte temporary restraining order ("TRO") against Aimee de Blasis Amann, a former global marketing director for Pfizer who had been at Pfizer since May 2006.  The TRO followed after Pfizer's emergency complaint that Ms Amann had misappropriated confidential information and trade secrets.  A copy of the TRO can be found here.  According to the complaint that was filed at the end of February 2017, Ms Amann had been responsible for marketing tofacitinib citrate for the treatment of rheumatoid arthritis (marketed as Xeljanz).  She resigned in early January.  Pfizer had sued Ms Amann alleging that she had forwarded to her personal email account 42 emails and compiled a USB drive containing hundreds of documents including strategic plans and product launch roadmaps immediately before resignation.  Judge Eduardo C Robreno, found that absent the interim restraining order, Pfizer:

"will suffer irreparable harm and injury to its operations and reputation, for which it has no adequate remedy at law. Upon consideration of these factors, the harm Defendant may suffer if injunctive relief is granted, the public interest, and all of the other legally required considerations, the Court determines that a temporary restraining order should be entered and this equitable relief should be granted."

In English parlance, the return date of the ex parte hearing was due to be held on Tuesday, but will now be held on 16 March 2017.  The TRO has been extended until then.

Despite the variety of industries and subject-matter, all of these cases follow a tried and tested model of trade secrets disputes - high level employees in trusted positions and/or teams with access with to highly confidential information going to the heart of a company's R&D - either in the product itself (LiDAR and process optimization) or in the commercialization of that product (commercial launch plans) - leave to a competitor or suddenly resign without telling their former company where they are going.  Cue the complaint.  However, with all of these cases, the claimants will have the burden of convincing the court that the information subject to these complaints are indeed trade secrets.  That is not always such an easy task.

With trade secrets cases continuing a pace in the US after the introduction of the DTSA and national legislation being completed in advance of next year's deadline for the implementation of the European Trade Secrets Directive, the AmeriKat promises that you will also start seeing trade secrets cases popping up everywhere you look.